MAUDE Adverse Event Report: GALDERMA Q-MED AB RESTYLANE LYFT LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Lot Number 19160-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Purulent Discharge (1812); Nausea (1970); Tachycardia (2095); Deformity/ Disfigurement (2360); Skin Infection (4544); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/13/2021

Event Type  Injury  

Event Description

Case (b)(4) is a spontaneous report sent on 06-dec-2021 by a physician which refers to a (b)(6) female patient.The patient was not pregnant neither breastfeeding.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On (b)(6) 2021, the patient received treatment with 2 ml restylane lyft lidocaine (lot 19160-1) to mental area using cannula 22g and co-packed needle with unknown injection technique.The patient had not received restylane lyft previously.On (b)(6) 2021, the patient started experiencing two pimples (acne) and infectious focus (biofilm) (implant site infection) in mental area.In (b)(6) 2021 (15 days after injection), the patient returned to physician's office experiencing abscess (implant site abscess).As a corrective treatment, the reporting physician performed drainage successfully.In 2021, an unspecified oral corticoid [corticosteroid nos] was initiated as a treatment for a short period of time.After starting the corticoid, the patient did not tolerate it and experienced tachycardia (tachycardia).As an action, the corticoid dose was gradually decreased and then suspended.On an unknown date in 2021, the patient underwent an ultrasonography which showed the evidence of secretion and occlusion was denied.On an unknown date in 2021, clarithromycin [clarithromycin] and avalox [moxifloxacin hydrochloride] were initiated as a treatment.After starting clarithromycin and avalox, the patient experienced nausea (nausea).On unknown date in 2021, the clarithromycin and avalox were discontinued and treatment was changed to bactrim [sulfamethoxazole, trimethoprim] which was used for 10-14 days.After starting bactrim, the patient continued experiencing purulent secretion (purulent discharge).In (b)(6) 2021 (4 weeks before the date of report), the patient received the treatment with clarithromycin and ciprofloxacin [ciprofloxacin].The patient was not hospitalized due to the adverse event.In (b)(6) 2021, the patient was evaluated by an infectiologist who requested the interruption of the treatment for culture test and results were not available yet.On an unknown date in 2021, some days after starting the antibiotic therapy, the patient was injected with hyaluronidase [hyaluronidase] locally.The patient underwent serum lab tests and result was normal.The patient underwent magnetic resonance exam, which showed only inflammatory process (implant site inflammation) without bone impairment.In (b)(6) 2021 (one week before the date of the report), the patient experienced skin retraction (cutaneous contour deformity) in mental area.During the contact with galderma's physician consultant, the possibility of diagnosis as an infectious focus (biofilm) was considered (as reported).According to the physician, the patient would continue the antibiotic therapy for 3-6 months.Outcome at the time of the report: abscess was unknown.Infectious focus (biofilm) was unknown.Inflammatory process was unknown.Tachycardia was unknown.Nausea was unknown.Pimples was unknown.Purulent secretion was unknown.Skin retraction was unknown.Tracking list: v.0 initial, v.1 fu received on 07-dec-2021 from same reporter.Patient demographics, suspect device implant date, volume, needle type, event onset date, laboratory data and corrective treatment details were updated.V.2 fu received on 10-dec-2021 from same reporter.Case upgraded to serious.Events (implant site abscess, inflammation, purulent discharge, cutaneous contour deformity, tachycardia and nausea) added.Verbatim of event implant site infection updated.Outcome of events, laboratory tests and corrective treatment details were updated.

Manufacturer Narrative

Company comment: the serious events of abscess, infection and inflammation at implant site, and the non-serious events of acne, purulent discharge and cutaneous contour deformity were considered expected and possibly related to the treatment.Serious criteria include the need for surgical and multiple medical interventions to prevent permanent damage.Potential root cause include injection procedure associated with inadequate aseptic technique.The non-serious events of tachycardia and nausea were considered unexpected and unrelated to the treatment as the alternative root cause include drug reactions from corrective treatments.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.A repeated batch record review will be performed to exclude a non-conforming product.

Manufacturer Narrative

Company comment: the serious events of staphylococcal infection, staphylococcal abscess, inflammation at implant site and the nonserious events of acne, purulent discharge and cutaneous contour deformity were considered expected and possibly related to the treatment.Serious criteria include the need for surgical and multiple medical interventions to prevent permanent damage.Potential root cause include injection procedure associated with inadequate aseptic technique.The non-serious events of tachycardia and nausea were considered unexpected and unrelated to the treatment as the alternative root cause include drug reactions from corrective treatments.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.Until this date, no adverse events have been reported on the lot.No potential quality issues have been identified in the manufacturing process of the specified batch.The batch is manufactured and released according to galderma quality management system.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.

Event Description

Case reference number: (b)(4) is a spontaneous report sent on 06-dec-2021 by a physician which refers to a 36-year-old female patient.The patient was not pregnant neither breastfeeding.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On (b)(6) 2021, the patient received treatment with 2 ml restylane lyft lidocaine (lot: 19160-1) to mental area using cannula 22g and co-packed needle with unknown injection technique.The patient had not received restylane lyft previously.On (b)(6) 2021, the patient started experiencing two pimples (acne) and infectious focus (biofilm) (staphylococcus epidermidis) (staphylococcal infection) in mental area.On (b)(6) 2021 (15 days after injection), the patient returned to physician's office experiencing abscess (staphylococcus epidermidis) (staphylococcal abscess).As a corrective treatment, the reporting physician performed drainage successfully.In 2021, an unspecified oral corticoid [corticosteroid nos] was initiated as a treatment for a short period of time.After starting the corticoid, the patient did not tolerate it and experienced tachycardia (tachycardia).As an action, the corticoid dose was gradually decreased and then suspended.On an unknown date in 2021, the patient underwent an ultrasonography which showed the evidence of secretion and occlusion was denied.On an unknown date in 2021, clarithromycin [clarithromycin] and avalox [moxifloxacin hydrochloride] were initiated as a treatment.After starting clarithromycin and avalox, the patient experienced nausea (nausea).On unknown date in 2021, the clarithromycin and avalox were discontinued and treatment was changed to bactrim [sulfamethoxazole, trimethoprim], which was used for 10-14 days.After starting bactrim, the patient continued experiencing purulent secretion (purulent discharge).On (b)(6) 2021 (4 weeks before the date of report), the patient received the treatment with clarithromycin and ciprofloxacin [ciproflaxacin].The patient was not hospitalized due to the adverse event.On (b)(6) 2021, the patient was evaluated by an infectologist who requested the interruption of the treatment for culture test.The result of the culture test was reported as staphylococcus epidermidis resistant to some antibiotics such as ciprofloxacin that patient was being treated.On an unknown date in 2021, after the culture result, the patient was treated with cefuroxime [cefuroxime] and rifampicin [rifampicin].On an unknown date in 2021, some days after starting the antibiotic therapy, the patient was injected with hyaluronidase [hyaluronidase] locally.The patient underwent serum lab tests and result was normal.The patient underwent magnetic resonance exam, which showed only inflammatory process (implant site inflammation) without bone impairment.On (b)(6) 2021 (one week before the date of the report), the patient experienced skin retraction (cutaneous contour deformity) in mental area.During the contact with (b)(6) physician consultant, the possibility of diagnosis as an infectious focus (biofilm) was considered (as reported).According to the physician, the patient would continue the antibiotic therapy for 3-6 months.At the time of this report, treatment with cefuroxime and rifampicin was ongoing.Outcome at the time of the report: abscess (staphylococcus epidermidis) was unknown.Infectious focus (biofilm) (staphylococcus epidermidis) was unknown.Inflammatory process was unknown.Staphylococcus epidermidis was unknown.Tachycardia was unknown.Nausea was unknown.Pimples was unknown.Purulent secretion was unknown.Skin retraction was unknown.Tracking list: v.0 initial, v.1 fu received on 07-dec-2021 from same reporter.Patient demographics, suspect device implant date, volume, needle type, event onset date, laboratory data and corrective treatment details were updated.V.2 fu received on 10-dec-2021 from same reporter.Case upgraded to serious.Events (implant site abscess, inflammation, purulent discharge, cutaneous contour deformity, tachycardia and nausea) added.Event implant site infection updated.Outcome of events, laboratory tests and corrective treatment details were updated.V.3 fu received on 21-dec-2021 from same reporter.Coding of events (abscess and infection at implant site) were updated.The reporter confirmed that the suspect device was restylane lyft lidocaine.Culture test results and corrective treatment details were updated.Brr results were received.

• Brand Name: RESTYLANE LYFT LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 13078429
• MDR Text Key: 284867258
• Report Number: 9710154-2021-00078
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P040024/S073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Lot Number: 19160-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female